Closure medical device and delivery mechanism

ABSTRACT

A delivery mechanism for deploying a closure device includes several slidable members, a plunger, and attachments to tension members of the closure device. Deployment of the closure device includes controlling placement and expansion of the device within tissue using the tension members, the plunger, and the slidable members.

CONTINUITY INFORMATION

The application is a continuation of application U.S. Ser. No.11/849,244 filed Aug. 30, 2007, (published Mar. 5, 2009 as2009/0062850), now U.S. Pat. No. 8,172,871 the claims of which wereallowed Feb. 14, 2012. The application also claims priority to the PCTapplication PCT/US08/74951 filed Aug. 30, 2008, published WO2009/029914, on Mar. 5, 2009. All referenced applications are herebyincorporated by reference in their entirety.

BACKGROUND OF THE INVENTION

Many vascular procedures can be accomplished by minimal invasion,typically by accessing the femoral artery or another major blood vessel,and through that vessel accessing the heart, brain, or other site thatrequires surgical attention. When the procedure is completed a holeremains in the accessed vessel that needs to be closed. The goal ofrepair of the puncture wound is to create hemostasis in the tissuetract, and to allow the puncture hole in the vascular lumen to seal,allowing blood to eventually re-flow through the lumen withoutthrombosis or embolism, and also allowing the tissue in the tissue tractleading to the vessel to heal.

The earliest methodology of closing puncture wounds in vascular lumenswas direct physical pressure which is first applied by a person (usuallya physician or nurse or aid) for up to an hour. After the initialapplication of manual pressure, a “C” clamp is fixed at the puncturesite to finish the closure. Usually during application of the “C” clampthe patient is immobilized for 6 to 8 hours. The “C” clamp method can bepainful and as with manual direct pressure requires immobilization. Thedrawbacks of direct pressure at the site include that a trainedprofessional is monopolized with the task for a relatively long periodof time, there is a risk of thrombosis or embolization during theprocess of applying pressure, the circulation is cut off in the lumenwhen the pressure is being applied, the patient is immobilized duringapplication of the pressure, and it is painful. The pressure methodsgenerally require also that the patient be catheterized for urinaryoutput during the 8 or so hours while the wound is closing underpressure from the “C” clamp so that the patient can remain completelyimmobilized until the wound has closed sufficiently to stop any bleedingfrom the artery. Even today, despite the discomfort and extended carerequired while applying direct pressure and waiting for the wound toheal, direct pressure, either by manual application or a “C” clamp, or acombination of both, is the standard of care. About 70% or all closurerequirements are met with this crude and seemingly archaic method ofclosure by application of direct pressure.

As an alternative to direct pressure, inventors and companies havedeveloped various devices for wound closure at a vascular puncture site.Accordingly, on the market today are various items including:biodegradable plugs, suture, staples, ultrasound, collagen, collagenwith thrombin, collagen with an anchor, and hemostatic patches and pads.These commercial alternatives to direct pressure include Kensey Nash'sAngioSeal that places a member in the artery from which a secondoperation can be facilitated to add a plug on the outside of the artery.Abbott's Perclose system sutures the site using a remote accessintroducer. Also available are Datascope's VasoSeal, Vascular Solutions'Duett, Sutura's vascular suturing system, and Marine PolymerTechnologies' Syvek. Of the 30% of the market that uses these devicesinstead of direct pressure, the devices used most often are AngioSeal(46%), PerClose (32%), VasoSeal (14%), and Duett (3%). Obese patientsare among the best candidates for these alternatives because directpressure on an obese person can be less effective than necessary forcomplete closure of the puncture site. Some of these methods or deviceshave proved unreliable, generating thrombosis, or requiring placementseveral times before they are effective. Although these devices areexpensive, successful use of them, can reduce the overall cost of theprocedure if use of the device causes the patient to be ambulatorysooner and require less attendant care and less hospital time as aresult.

It would be advantageous to the field of percutaneous and otherwiseminimally invasive surgery (including particularly cardiac andcardiac-related surgery) to offer a system of vascular closure that issimple and capable of providing reliable hemostasis in the accessedvessel at a cost that can justify incorporation of the device intoroutine practice. In addition, present practice sometimes indicatesusing two or more devices to accomplish the closure, and it would beoptimal to provide a single effective device that reliably closes thepuncture site every time. In addition, it would be desirable toaccomplish closure without suture, and without the need to apply directpressure, even as an adjunctive therapy. The present inventionaccomplishes these and other goals.

SUMMARY OF THE INVENTION

The invention is a device for closing a puncture wound in a mammalianbody, particularly a human body. The typical situation where this deviceis used is after a minimally invasive procedure where the heart orrelated vessels are accessed through the femoral artery. After theprocedure, a hole remains in the femoral artery that can bleed unlessclosed. The invention is a device that can be placed into the femoralartery and through the hole and within the exiting tissue tract.

A delivery sheath holding the device is placed through the introducersheath that is already in the tissue tract and femoral artery from theminimally invasive procedure. When deployed the device closes the tissuetract and seals the puncture within the femoral artery shut so that thepatient does not bleed into the tissue tract and blood can resume normalflow through the artery.

The wound to be closed can be any puncture wound, particularly woundscaused in percutaneous minimally invasive surgery where an artery suchas a femoral artery is accessed using a catheter. Removal of thecatheter and its introducer sheath after the procedure results in a holeleading from the vessel. Bleeding will ensue if the hole is not pluggedeither by thrombosis created by direct pressure or some device to closethe hole. The device of the invention closes the puncture hole, and canalso close a similar hole left after access to a cavity or other bodyvessel. The device is deliverable in a delivery sheath, and the deliverysheath is optimally passed through the introducer sheath already inplace from the surgery that was the purpose of creating the puncturewound in the first place. The puncture wound typically has a lengthalong a tissue tract that leads from the puncture in the vessel orcavity to the skin, the tissue tract resolving in an interior opening ofthe vessel or cavity.

The closure device will have minimally a distal section for placinginside the interior opening of the vessel or cavity. The distal sectionis lodged in a delivery sheath to effect delivery to the vessel alongthe tissue tract that was already created with the introducer sheath forthe percutaneous procedure. The delivery sheath has a proximal end atthe skin surface and a distal end close to the interior of the vessel orcavity where the distal section is to be delivered. The delivery sheathis capable of penetrating the wound along the length of the wound topass through the interior opening of the vessel and release the distalsection. The distal section is released using a plunger that slides overa tension member. The tension member is affixed to the distal sectionand tension placed on the tension member. The tension member istypically a suture or string or other type of strand or linear memberable to withstand tension and it controls the placement anddirectionality and seating of the distal section at the vessel or cavitywall, in coordination with the action of the plunger in the deliverysheath that pushes the distal section out from the sheath while tensionis placed on the distal section by pulling the tension member proximallytoward the skin surface. In this manner a distal section having a stifffront end is released from the delivery sheath and rotated 90 degrees sothat the stiff front end is now turned perpendicular to the opening ofthe delivery sheath, and is no longer parallel to it. The distal sectionof the device when seated in the vessel or cavity wall providesresistance against the interior opening, allowing for the placement andadjustment of the rest of the device.

The device also minimally comprises a proximal section connected to thedistal section. The proximal section comprises a bunchable materialcapable of bunching in the tissue tract upon deployment. As the proximalsection releases from the delivery sheath it is unbunched, but tensionplaced on the tension member, which is a string or strand runningthrough the bunchable material, causes the material to bunch and fold inthe tissue tract. The device also minimally has at least one tensionmember that is a string or strand connected to the distal section andeither the same or a different tension member connected to the proximalsection for pulling each section. Pulling on the tension member adjuststhe position of the distal section, and bunches the proximal section.Positioning of the device in the body is with the distal section seatedagainst the interior of the vessel wall, and the proximal sectionbunched in the tissue tract. The tension member or tension members areleft to reside in the device and can be clipped at the skin level. Theend or ends of a tension member at the skin surface can be used toretrieve the closure device if it was not positioned properly, or if forany reason the closure device needs to be removed or readjusted.

The configuration and placement of the tension member in the device canbe important. The tension member can be a single string knotted at thedistal section and threaded through the proximal section. Alternatively,the tension member can be looped through the distal section and proximalsections, effectively providing for two ends at the proximal section ofthe device near the skin surface. In order to pull the looped tensionmember effectively, the tension member can be slip knotted to itself inthe proximal section so that pulling on the string resulting from theslip knot bunches the material as the slip knot travels down the devicetoward the distal section. This activity can be facilitated better usinga plunger that pushes the device away from the skin surface and towardsthe vessel opening, while the tension member with its slip knot ispulled back towards the skin surface to provide the tension necessaryfor positioning the distal section and bunching the proximal section.

Several configurations of the tension member can be used including thatthe tension member is looped through the distal section and proximalsection using a single tension member having first and second proximalends (ends residing at or near the skin surface). The tension member canalso pass through the distal section and the proximal section once andbe knotted at said distal section, so that there is only a single end atthe proximal section. A slip knot configuration of the tension memberprovides greater tension and control on the bunching material, and isachieved by having two ends of the same tension member (created when thetension member is threaded or looped through the material) then forminga slip knot with one of the ends around the other end so that pullingthe single remaining thread of the slip knot causes the material tocompress. The pulling of the tension member is usually done incoordination with the pushing of a plunger away from the skin andtowards the vessel or cavity opening.

Another variation of the device includes a middle section positionedbetween the distal section and the proximal section. Although the middlesection can be the same width as the proximal section, the middlesection is optimally a narrow short section for passing from the vesselto the tissue tract. The middle section is connected to the distalsection so that upon rotation of the distal section, the middle sectionremains exterior to the vessel or cavity, remaining in connection withthe distal section. The middle section is optimally significantlynarrower than the distal section (the rotated distal section) so as toprovide minimal disturbance between the interior opening of the vesselor cavity and the tissue tract.

Following from the middle section in this variation is the proximalsection that bunches as before. A single tension member can control allthree sections, or two tension members can be used, one controlling thedistal section, and another controlling the middle and proximal sectionstogether. Also, the middle section does not necessarily need to have atension member controlling it at all, so that two tension members can beused, one for the distal section and one for the proximal section. Thesecond tension member can start in the middle section or can miss themiddle section altogether and start in the proximal section because themiddle section is so short and narrow it does not bunch much if at all,nor is it important for it to bunch, but rather the middle section actsas a placeholder or a distancer to separate the distal from the proximalsections and provide the least possible trauma at the vessel or cavityopening. The knotting of the tension members can have the samevariations as described previously, ie. a single thread knotted at thedistal section, a single thread knotted at the proximal section, asingle thread looped through all sections with two ends at the skinsurface, the two ends at the skin surface forming a slip knot, or both asingle thread looped at the vessel end of the proximal section with twoends at the skin surface, preferably controlled by a slip knot there.

Yet another variation of the device includes a distal section, a middlesection, a proximal section and two tension members in essentially thesame configurations as described previously. The only difference in thisvariation is that after the proximal section has been bunched using thesecond tension member, the first tension member is used to pull thedistal section from its seat in the interior of the vessel or cavitywall into the beginning of the tissue tract to reside adjacent to orjust in front of the middle section. This variation is depicted in FIGS.6A, 6B, and 6C.

Methods of closing a puncture wound include using each of the describedvariations as depicted in a procedure to close a puncture wound.Accordingly, the wound can be closed with a device having a distal andproximal section and a single tension member; a distal and proximalsection and two tension members; a distal, proximal, and middle sectionhaving two tension members; and a distal, proximal and middle sectionhaving two tension members where the first tension member is capable ofpulling the distal section out of the interior of the vessel or cavityfor final configuration of the device entirely outside the vessel orcavity.

The tension member can also be fixed by one knot in the tension memberat the distal section. The rest of the tension member is threadedthrough the material and pulling on the tension member while the plungerpushes against the material accomplishes the necessary activity fordeploying the device. An alternative configuration for any of thetension members is a slip knot formed at or near the skin surface forbetter pulling on the tension member and control or bunching of thedistal or proximal sections.

The distal, middle and proximal sections can comprise any suitablebiocompatible material. Preferred material is material that willbioabsorb or biodegrade at about the rate that the wound will heal.Accordingly, materials that may be used to make the device include butare not limited to polyglycolytic acid (PGA), PGLA, PLA, polydioxanone,polycaprolactone, polyhydroxybutyrate, collagen, a polymer matrix,extracellular matrix, silk, Dacron, polytetrafluoroethylene (PTFE),expanded polytetrafluoroethylene (EPTFE), a metal, a metal alloy, aplastic, an elastic material, a polymer, an inert material, a fusedsegment of material, a melted segment of material, a fabric, a braid, aweave, and a foldable material.

Similarly, the tension members can comprise materials that havesufficient tensile strength to withstand the pulling activity, and thatalso, sometime when the wound has healed will itself biodegrade. Thus,the tension member can comprise a material selected from the groupconsisting of polyglycolytic acid (PGA), polyglycolytic lactic acide(PGLA), polylactide (PLA), polydioxanone, polycaprolactone,polyhydroxybutyrate, collagen, a polymer matrix, extracellular matrix,silk, Dacron, suture, a bioabsorbable material, a biodegradablematerial, a biocompatible material, a metal, a metal alloy, a plastic,an elastic material, a polymer, an inert material, a thread, and astrand.

Other variations of the device include the elements just describedabove, with some notable additions or differences. One variationincludes a device where the distal section and the proximal section eachhave their own separate tension members. As with all the tension membersof the variations, these tension members can be looped with a slip knot,or singly threaded through with an end knot.

The first tension member controls and seats the distal section and thesecond tension member bunches and positions the proximal section. Theprocess of placing the device includes the activities of pushing theplunger distally in the delivery sheath so that the distal section isdeployed, rotating the distal section about 90 degrees once inside thevessel or cavity by pulling on a tension member that controls the distalsection (i.e. is attached to it), seating the distal section in itsrotated state against the wall of the vessel or cavity, withdrawing theintroducer sheath and delivery sheath gradually along the tissue tractwhile pushing with the plunger to expel the proximal section in thetissue tract, and bunching the proximal section by pulling on thetension member somewhat simultaneously as the plunger is being pushedtoward the vessel or cavity opening. The methods can further includelocking the delivery sheath (which resides within the introducer sheathduring much of the delivery process) within the introducer sheath.

The invention also includes a mechanism for delivering the closuredevices that includes a delivery sheath having distal and proximal ends,a tension member control arm at the proximal end for allowing pull onthe tension member to place the distal section and bunch the proximalsection. The mechanism also comprises a plunger that resides within thedelivery sheath with one or more tension members running through it sothat the tension members can be pulled while the plunger is pushed toeffect delivery of the device.

Another variation of the device is a closure device for closing apuncture wound, the device deliverable in a delivery sheath, thepuncture wound having a length along a tissue tract that resolves in aninterior opening of a vessel having fluid flow, the closure devicecomprising a short stiff front section capable of rotation 90 degreesupon placement inside said vessel for seating the device in the vessel,the short front section having a first tension member for seating it,and the short front section connected to a long bunchable back sectionthat bunches upon deployment from the delivery sheath using a plunger topush it out from the delivery sheath and a second tension member runningthrough a bunchable section to pull against the seated front section inopposition to the plunging action to release the long back section fromthe delivery sheath and to bunch it in the tissue tract.

Yet another variation of the device provides that the device is as justdescribed and additionally the short stiff front section bends at amidline after said long bunchable back section is bunched using thefirst tension member to withdraw the short stiff front section from theinterior opening and bend it into the tissue tract in front of the longbunched back section, thereby clearing the vessel of the device andproviding unobstructed fluid flow in the vessel.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A depicts a side view of one embodiment of the device having adistal section, a proximal section, and a tension member looped throughboth sections with a slip knot at the proximal end.

FIG. 1B depicts a flat view of the device of FIG. 1A with the distalsection, proximal section and tension member looped through both of themwith a proximal slip knots.

FIG. 1C depicts another embodiment of the device with a distal section,proximal section, and tension member looped through both, the tensionmember ending with an end knot at one of the two proximal ends.

FIG. 1D depicts the proximal most end of the embodiment of FIG. 1Chaving an end loop knot instead of an end knot.

FIG. 1E depicts another embodiment of the device having a distalsection, a proximal section, and a tension member through both of them,with an anchoring end knot in the distal section.

FIG. 1F depicts the distal end of the device of FIG. 1E having a loopedknot for anchoring the tension member in the distal section.

FIG. 2A depicts a side view of a partially folded device having a distalsection, a proximal section and two tension members, one in the distalsection and passing through the proximal section also and one throughjust the proximal section. The embodiment of FIG. 2A depicts a slip knotat an end of the tension member in the distal section, and a slip knotat one end of the tension member that runs through the proximal section.

FIG. 2B depicts a flat view of the device of FIG. 2A showing the loopedtension member through the distal section, ending in a slip knot, andthe looped tension member through the proximal section, ending in a slipknot proximal to the proximal end.

FIG. 2C depicts a flat view of another embodiment having two tensionmembers, where the proximal end of the proximal tension member isfinished in an end knot.

FIG. 2D depicts a variation of the embodiment of FIG. 2C showing alooped end knot to finish the tension member that runs through theproximal section.

FIG. 2E depicts an embodiment of the device having a distal end with atension member having an end knot at the top, the tension memberextending through the proximal section also, and a second tension memberin the proximal section that is looped around and has a slip knot at theend of the proximal section closest to the skin surface (the proximalend of the proximal section).

FIG. 2F is a version of the embodiment of FIG. 2E that has a looped knotat the distal section to hold the single tension member in the distalsection, and is otherwise the same with respect to the second tensionmember.

FIG. 3A is a side view of an embodiment of the device having a distalsection, a middle section, and a proximal section. This particularembodiment has two tension members, one in the distal section, andrunning also through the middle and proximal sections, and a secondtension member through the proximal section.

FIG. 3B is a flat view of the same embodiment as in FIG. 3A, having aslip knot in the second tension member at the proximal end, and an endknot in the first tension member at the distal section.

FIGS. 4A, 4B, and 4C depicts the embodiment of FIGS. 1A and 1B in thecontext of a vessel and tissue tract. FIG. 4A depicts the distal sectionplaced in the interior of the vessel and the proximal section beginningto bunch in the tissue tract. FIG. 4B depicts the proximal sectionfolding more extensively using the plunger of the delivery device toeffect the bunching along with the tension member. FIG. 4C depicts thedevice fully placed in the vessel and tissue tract, and the deliverydevice removed.

FIG. 5A depicts the embodiment of FIGS. 2A and 2B in the context of avessel and tissue tract. FIG. 5A depicts the distal section placed inthe interior of the vessel having the tension member with a slip knot,and the proximal section beginning to bunch in the tissue tract. FIG. 5Bdepicts the proximal section almost completely bunched having theplunger of the delivery device pushed distally to bunch the proximalsection along with pulling on the second tension member having a slipknot. FIG. 5C depicts the device completely placed in the vessel andtissue tract and the delivery device removed.

FIGS. 6A, 6B, 6C, and 6D depicts the embodiment of FIGS. 3A and 3B inthe context of a vessel and tissue tract. FIG. 6A depicts the distalsection placed in the interior of the vessel and the proximal sectionbeginning to bunch in the tissue tract. FIG. 6B depicts the middlesection bunching slightly, and the proximal section bunching completelyin the tissue tract using the plunger of the delivery device and thesecond tension member having a slip knot. FIG. 6C depicts the middlesection bunching and the proximal section completely bunched in thetissue tract, and the distal section beginning to bend in half. FIG. 6Ddepicts the device with the distal section completely withdrawn from theinterior of the vessel to reside bunched with the middle section in theearly part of the tissue tract, and following that the proximal sectioncompletely bunched in the tissue tract, with the delivery devicecompletely withdrawn.

FIG. 7A through 7F depicts the mechanism that controls the deliverysheath to deliver the device in the vessel and tissue tract. The deviceembodied in FIG. 1 is used as an example of how the mechanism wouldoperate for any of the embodiments of the invention. FIG. 7A shows thedelivery sheath locking into the introducer sheath with the distal endof the delivery sheath. FIG. 7B depicts the mechanism which providesboth tension on the tension members and motion with the plunger usingthe movement of the block to push the plunger into the delivery sheaththat is locked into the introducer sheath with a control arm at theproximal end of the delivery sheath for simultaneously applying tensionon the tension member or members. FIG. 7C depicts the delivery sheathsliding into the introducer sheath. FIG. 7D depicts the delivery sheathlocked into the introducer sheath and extending into the introducersheath and beyond the distal end of it into the interior of the vessel.The distal section of the closure device extends beyond the distal endof the delivery sheath in a “T” formation in preparation for placing thedistal section of the closure device at the interior of the vessel wall.The device also depicts a control arm for controlling the tension memberor members and plunger. FIG. 7E depicts the delivery sheath extendingthrough the introducer sheath with the delivery sheath and introducersheath extended into the interior of the vessel, with the distal end ofthe delivery sheath extending beyond the introducer sheath, and thedistal section of the closure device protruding from the distal end ofthe delivery sheath in a “T” formation in preparation for placing thedistal section of the closure device at the interior wall of the vessel.FIG. 7F depicts a cross-sectional view of the delivery mechanism fordelivering the device.

FIG. 8A-8C depicts the mechanism for placing and the deploying theclosure device.

DETAILED DESCRIPTION OF THE INVENTION

The closure device is made of a bunchable material that bunches withinthe tissue tract. The device is delivered in a delivery sheath throughthe introducer sheath through the tissue tract to a vessel having apuncture hole. The distal end of the device is seated against the vesselwall and material comprising the proximal section of the device isbunched within the tissue tract to provide an environment for bloodcoagulation, closure of the puncture hole and sealing the space withinthe tissue tract. The material of the device is a biocompatible materialand can be partly or fully bioabsorbable or biodegradable.

Turning now to the figures, FIG. 1A-1F depict the general embodiment ofa device 17 having a distal section, a proximal section and a singletension member running through both the distal section and proximalsections and controlled by proximal ends that are proximal to theproximal section. That being said, FIG. 1A depicts a side view of anembodiment of device 17 having a distal section 2 and a proximal section4. The distal section 2 has a tension member 8 that loops through boththe distal section 2 and the proximal section 4, weaving in and out ofthe bunchable material 6, and having a first proximal end 10 and asecond proximal end 12 and a slip knot 14 that is tied by first proximalend 10 around second proximal end 12. FIG. 1B is a flatter view of thesame device 17 as depicted in FIG. 1A, having the tension member 8 thatloops around in the distal section 2 and through the proximal section 4,with a first proximal end 10 and a second proximal end 12 resulting inends 10 and 12 at the proximal section 4. Slip knot 14 is made usingfirst proximal end 10 around second proximal end 12.

FIG. 1C is a slightly different embodiment of 17 from FIGS. 1A and 1B inthat end knot 15 is used in the proximal section 4 with first proximalend 10 instead of a slip knot. Tension member 8 is looped through boththe distal section 2 and the proximal section 4, and also results insecond proximal end 12. Pulling on second proximal end 12 bunches thebunchable material 6. FIG. 1D presents yet another embodiment of device17 providing a looped knot 16 using proximal end 10, and leaving freeand dangling second proximal end 12. In any of these embodiments theknots may be looped knots or end knots, provided they hold the tensionmember at the position of the knot in the material where the tensionmember is attached by a knot.

FIG. 1E depicts an embodiment of the device 17 where a single tensionmember 22 is run through both the distal section 2 and the proximalsection 4, having an anchor knot 20 in the distal section, and aproximal end 18 at the proximal section. FIG. 1F depicts a slightvariation on this embodiment depicting a looped knot anchor 24 in thedistal section 2, with tension member 22 running also through proximalsection 4.

FIG. 2A through 2F depict another several embodiments in a device 31that have some elements in common, that is having a distal section andproximal section, and a first and second tension member. Accordingly,turning to FIGS. 2A and 2B there is depicted a side view of device 31 inFIG. 2A and a flat view in FIG. 2B of a device 31 having a distalsection 2 and a proximal section 4, and a bunchable material 6comprising the proximal section 4. First tension member 26 in distalsection 2 ends in slip knot 40. First tension member 26 extends alsothrough proximal section. Proximal end 30 of second tension member 28extends from proximal section 4 through bunchable material 6, formingslip knot 34 around other proximal end 32.

FIGS. 2C and 2D depict an embodiment of device 31 having an anchor knot36 in second tension member 28 having proximal ends 30 and 32 resultingfrom proximal section 4. Distal section 2 has first tension member 26and slip knot 40. FIG. 2D illustrates a looped anchor knot 16 with end30 instead of the straight anchor knot 36 of FIG. 2C. Ends 32 and 26emerge at the proximal end in FIG. 2D as with FIG. 2C. Having first andsecond tension members allows the practitioner to first position thedistal section 2 and then to bunch the proximal section 4 in the tissuetract.

FIGS. 2E and 2F depict an embodiment of device 31 also having the twotension members, a first tension member 26 in distal section 2 and asecond tension member 28 in proximal section 4. FIG. 2E depicts ananchor knot 20 in first tension member 26 in distal section 2, and FIG.2F depicts a looped anchor knot 24 in first tension member 26 in distalsection 2. Both FIGS. 2E and 2F depict first tension member resolving inthe proximal section 4, and both FIGS. 2E and 2F also depicts secondtension member 28 resolving in first and second proximal ends 30 and 32in proximal section 4. Slip knot 34 secures and controls second tensionmember 30 around second proximal end 32.

FIGS. 3A and 3B depict side view and flat view respectively of anembodiment of device 43 having a distal section 50, a middle section 52and a proximal section 54. Distal section 50 has first tension member 56having slip knot 60. First tension member 56 also weaves through middlesection 52 and proximal section 54 to resolve at the proximal most partof proximal section 54. Second tension member 58 begins at proximalsection 54 and loops around to finish proximally in ends 68 and 66, end68 forming a slip knot 62 around end 66. Proximal section 54 and middlesection 52 are made of bunchable material 64 as depicted in the sideview of device 43 in FIG. 3A.

FIGS. 4A, 4B and 4C depict an embodiment of the device 17 having adistal section 84, proximal section 86 and tension member 96 in a vessel82, through a vessel opening 70, and within a tissue tract 80. Thedelivery sheath 72 fits within the introducer sheath 78 within thetissue tract 80. The distal section 84 is placed up against the interiorwall of the vessel 82. Tension member 90 is looped through distalsection 84 and proximal section 86, and resolves in ends 94 and 96, withslip knot 92 actuated by plunger 88 moving toward the distal sectionagainst delivery sheath wall 76. FIG. 4B depicts device 17 having thedistal section 84 placed in the vessel 82 and having the proximalsection 86 bunched by pushing on the plunger 88 along plunger wall 76within delivery sheath 72 which is within introducer sheath 78 to movethe slip knot 92 towards the distal section 84 and bunching the materialof the proximal section 86 through the contraction of tension memberloop 90 having proximal ends 94 and 96. While the plunger 88 is movingdistally, tension is being placed on end 96 of tension member loop 90which causes the slip knot 92 to slide and the loop of tension member 90to tighten. FIG. 4C depicts device 17 fully deployed in the tissue tract80 having distal section 84 placed in vessel 82, and proximal section 86completely bunched in tissue tract 80, having slip knot 92 pushedtightly against proximal section 86 and having short end 94 and longerend 96 resting in tissue tract 80. The delivery sheath 72 and introducersheath 78 of device 17 of FIG. 4B are removed and blood is allowed toflow through vessel 82 without leaking from opening 70 (opening 70depicted in FIG. 4A).

FIGS. 5A, 5B and 5C depicts the embodiment of the device 31 having adistal section, a proximal section and first and second tension members.FIG. 5A depicts distal section 2 placed within the opening 70 and seatedin vessel 82. First tension member 26 holds distal section 2 in placeusing slip knot 40. Proximal section 4 made of bunchable material beginsto bunch in device 31 in FIG. 5A using ends 30 and 32, the end 30forming slip knot 34. Plunger 88 of delivery sheath 72 is placed withinthe introducer sheath 78, all placed within tissue tract 80. As thedevice 31 gets deployed in FIG. 5B slip knot 34 tightens over end 32using end 30, pushed by pusher 88 against delivery sheath wall 76through delivery sheath 72, within introducer sheath 78 in tissue tract80. As a result of the bunching of proximal section 4, first tensionmember 26 and second tension member 28 are pulled tightly throughproximal section 4 as pusher 88 moves up through delivery sheath 72against delivery sheath wall 76. FIG. 5C depicts the fully deployeddevice 31 having distal section 2 placed flatly in vessel 82 andproximal section 4 bunched tightly up against slip knot 40, having slipknot 34 pushed tightly against proximal section 4, with ends 30, 32 and26 remaining in the tissue tract after removal of the delivery sheathand introducer sheath.

FIGS. 6A, 6B, 6C and 6D depict device 43 having a distal section 110, amiddle section 112, and a proximal section 114 with a first tensionmember 124, and a second tension member 126. FIG. 6A depicts deliverysheath 118 within introducer sheath 116 within tissue tract 120 withplunger 132 in delivery sheath 118, all positioned for actuation andrelease of device 43. In FIG. 6A distal section 110 of device 43 isalready placed in vessel 122. Slip knot 128 is tied over first tensionmember 124. Middle section 112 acts as a spacer to keep the proximalsection a measured distance from the outside of the vessel wall whilethe proximal section 114 is being bunched. The measured distance ismaintained for the purpose of later withdrawing the distal section 110from the vessel into the tissue tract adjacent to the middle section.The proximal section 114 bunches over second tension member 126 withsome tightening coming from slip knot 130 around second tension member126. FIG. 6B depicts device 43 having a middle section 112 in tissuetract 120 with slip knot 128 pushed tightly against distal section 110.Proximal section 114 is beginning to bunch in tissue tract 120, asintroducer sheath 116 and delivery sheath 118 are being withdrawn fromtissue tract 120 to release the bunchable material of proximal section114 over first tension member 124 and second tension member 126. FIG. 6Cdepicts full activation of plunger 132 through delivery sheath 118within introducer sheath 116 in tissue tract 120 with slip knot 130pushed tightly up against fully released and bunched proximal section114 in tissue tract 120 with first tension member 124 fully pulledagainst slip knot 128, and second tension member 126 is fully pulledagainst slip knot 130. Also in FIG. 6C, distal section 110 is beginningto fold in on itself in vessel 122, as tension is applied to firsttension member 124 for a second time. FIG. 6D depicts device 43 fullyreleased and positioned in tissue tract 120 (with delivery sheath 118and introducer sheath 116 removed), having distal section 110 fullyfolded in on itself and withdrawn from vessel 122 so that distal section110 is no longer in vessel 122, but rather outside it in the earlyportion of tissue tract 120, adjacent to the now bunched middle section112. Middle section 112 is compressed around distal section 110 in FIG.6D, and proximal section 114 is fully bunched against slip knot 130which is pulled along second tension member 126. First tension member124 is pulled tightly against slip knot 128.

FIG. 7A depicts the mechanism of delivery device 55, having deliverysheath 160, introducer sheath 168 locking member 162, plunger guideblock 170, and side port 172. The delivery sheath 160 fits insideintroducer sheath 168, and inside the delivery sheath resides theslidable plunger 132. The side port 172 provides access for flushing andother coordinate procedures to facilitate the process. Locking members162 allow the introducer sheath 168 to lock into place while plunger 132is still available to slide forward and back as needed for deployment ofthe device. The distal portion of the introducer sheath 164 defines theinterface where the delivery sheath slides through the introducer sheathto deliver the device.

FIG. 7B shows the distal portion 164 of introducer sheath 168, and thedelivery sheath 160 locked within introducer sheath 168. FIG. 7B alsodepicts the tension member anchor 166 around which one or more tensionmembers 96 can be strung and pulled, or otherwise controlled through thecenter of plunger 132.

FIG. 7C depicts the particular sliding and locking mechanism betweendelivery sheath 160 and introducer sheath 168 at plunger guide block170. Side port 172 is unaffected by the locking mechanism.

FIG. 7D shows further locking member 162 having introducer sheath 168locked around delivery sheath 160. Proximal end of plunger 132 is alsoshown, as is the tension member anchor 166 and proximal end of thetension member 96. Delivery sheath 160 is shown in vessel 174 havingdistal section 175 of the device released from the delivery sheath 160and rotated 90 degrees for eventual positioning at the wall of vessel174.

FIG. 7E depicts a closer view of the action depicted in FIG. 7D insidethe vessel 174, where the delivery sheath 160 is within introducersheath 168 within vessel 174, delivery sheath 160 having distal section175 released into vessel 174 and rotated 90 degrees for eventualplacement at the opening in vessel wall 174.

FIG. 7F depicts a side cross-sectional view of the delivery device andmechanism. Working back from the tip of the partially delivered device175, there is the tension member 96 that slips inside plunger 132, whichslides within delivery sheath 160, which is within introducer sheath168, from which side port 172 can be located for peripheral delivery offluids and such, resolving in a substantial proximal end of introducersheath 168, within which slides a middle portion of delivery sheath 160,and the introducer sheath 168 can lock into locking member 162 atcertain points in the delivery process. Plunger 132 continues to extendbeyond plunger guide block 170 which serves to slide plunger forward andback stably as needed. Tension member 96 extends beyond the plunger andis wrapped around fulcrum 171, and further controlled and placed intotension by wrapping around tension member anchor 166. Thus, it can beseen how several slidable members (notably the plunger 132, deliverysheath 160, and introducer sheath 168) control the placement of thedistal end 175 of the device and using tension on the tension member 96with the fulcrum 171 and tension anchor member 166, deploy the deviceinside the vessel wall and tissue tract.

FIG. 8A-8C depict the same mechanism as detailed in FIG. 7A-7F, but withthe addition of an actual movable handle 204 and some of its coordinateparts to facilitate the activities necessary to deliver the device. Inthe embodiment of FIG. 8A, the mechanism is open and the plunger driveblock 198 feeds forward and backward the plunger 132. Plunger guideblock 170 serves to guide the plunger 132 into the delivery (160) andintroducer (168) sheaths when the introducer sheath 168 is locked atlocking members 162. Introducer sheath 168 still contains deliverysheath 160 and plunger 132, and external to the skin puncture, side port172. Guide plate 200 holds and stabilizes fulcrum 171, plunger driveblock 198 and plunger guide block 170. The plunger 132 passes throughthe plunger guide block 170 and plunger drive block 198. Handle 204 andscissor arm 202 rotate over pivot 206 which moves the plunger driveblock 198 either closer or further away from the fulcrum 171 (dependingon whether the handle 204 is opening or closing), making the tensionmember 96 taught upon “closing” the handle 204; FIG. 8B depicts partialclosure of the mechanism to thus create pressure on tension member 96and move plunger 132 distally by closing handles 204. FIG. 8C depicts afurther closure from the intermediate closure depicted in FIG. 8B.Handle 204 is squeezed together and pivot 206 further pulls in scissorarm 202 which places the maximal pressure on tension member 96, whichtension in coordination with pushing of the plunger 132, allows thedevice to leave the delivery sheath and become deployed.

The bunchable material for the device is biocompatible and can also be abiodegradable material, and will preferably biodegrade within somereasonable period of time after placement at the puncture hole, roughlyequal to the healing time for the wound at the puncture hole and in thetissue tract. The material is in a form amendable to bunching and alsoamenable to intercalating with the tissue, cells and proteins of theenvironment at the puncture wound and in the tissue tract. The form ofthe material can include, for example, a weave or braid, or natural orsynthetic polymer matrix, or any material that can bunch. The braid maybe such that when placed in tension, stretches and thins and when placedunder compression, shortens and expands. One form of the device is onewhich folds upon itself thus increasing its surface area per unitlength.

The bunchable material of the device including any of any the sectionsof the device can be made of any bunchable materials or malleablematerials, some biodegradable and some not, for example polyglycoliticacid (PGA), polyglycolitic lactic acid (PGLA), polylactic acid (PLA),Polydioxanone, Polycaprolactone, Polyhydroxybutyrate, silk, nylon,collagen, extracellular matrix, polytetrafluoroethylene (PTFE), expandedpolytetrafluoroethylene (EPTFE), Dacron, a metal, a metal alloy, aplastic, an elastic material, a polymer, an inert material, a fusedsegment of material, a melted segment of material, a fabric, a braid, aweave, and a generally bunchable material. Similar materials to thesemay be used having the ability to provide bunchable layers that causeinterference to a blood flow and promote coagulation by blocking anyblood flow out of the puncture wound into the tissue tract. Also thebunching of material promotes healing and wound closure in the tissuetract. The material can be a single material or combination of one ormore materials. A natural polymer matrix can include an extracellularmatrix, such as derived from mammalian tissue including liver basementmembrane, urinary bladder submucosa, small intestine submucosa andstomach submucosa, which are known in the art. The matrix can also be asynthetic collagen-type or other matrix, of which many are known in theart. Sheet form of extracellular matrix can be cut to the proper shapeand formed in folding sheets with perforations for folding, and can alsobe threaded with a tension member as described in other embodiments. Theextracellular matrix should be made malleable and bunchable rather thanrigid and stiff, which may be possible if the material is soaked in asoftening solution that encourages the material to bunch withoutcracking and breaking.

The distal sections of these devices have a stiffened rod or stick ofmaterial at the distal most end, with maybe one bunched section afterthat before the device retreats into the tissue tract. The rod or stickcan be made by fusing the material of the device at the distal most end.The distal section will be turned in the delivery sheath to penetratethe vessel opening. After penetrating the vessel opening, the distalsection is rotated 90 degrees to seat against the vessel wall. Turningnow to the illustrations of FIG. 4, distal section 84 of the device 17in FIGS. 4A, 4B and 4C enters the puncture hole 70 as a point or tip andthe plunger 88 pushes the distal section 84 out into the vessel lumen 82while simultaneously tension is applied to the tension member end 96causing the tip of the distal section 84 to rotate 90 degrees. Deliverysheath 72 and introducer sheath 78 are withdrawn from the vessel untildistal section 84 seats firmly against vessel wall. Plunger 88 pushes upon proximal section 86 to encourage bunching of the material in tissuetract 80 using also tension that can be created on tension member 96having slip knot 92. As plunger 88 pushes distally, proximal section 86becomes completely folded and delivery sheath 72 and introducer sheath78 can be removed leaving fully deployed device 17 to block puncturehole 70 and tissue tract 88

Embodiment 31 in FIGS. 5A, 5B and 5C has a tension member in distalsection 2 and a tension member in proximal section 4. Separate tensionmembers provide for control of the distal section 2 first while placingit against the vessel wall of vessel 82. Secondly, control of theproximal section 4 is facilitated by pulling on the second tensionmember 28 and sliding slip knot 34 over end 32 to cause bunching ofproximal section 4 in tissue tract 80. Eventually the bunching iscomplete and the tissue tract 80 is sealed and the delivery sheath 72and introducer sheath 78 can be removed from tissue tract 80. Ends 26and 32 will remain in the tissue tract also with short end 30 and slipknot 34.

Embodiment 43 in FIGS. 6A, 6B, 6C and 6D is depicted being deployed invessel 122 and tissue tract 120. Embodiment 43 has a middle section 112.The middle section can be the same width as the proximal section 114 orit can be narrower. The advantage of a narrower middle section is thatthe middle section will disrupt the puncture hole less. The middlesection does not necessarily bunch but it can. Generally it acts as aconnector between the distal and proximal sections. Although the firsttension member 124 from the distal section 110 runs through the middlesection 112, the middle section 112 is bunched (if at all) essentiallyfrom the retraction of distal section 110 as shown in FIG. 6D. Thebunching of proximal section 114 occurs with the second tension member126 pulling up with the pressure from slip knot 130 along the secondtension member 126. Plunger 132 pushes the proximal section 114 upthrough the delivery sheath. After the proximal section 114 has bunchedas tightly as possible a second pull on the first tension member 124receives a new pull to retreat the distal section 110 out of the vessel122 and into the very first part of the tissue tract 120 next to themiddle section. This way a smooth unoccluded vessel 122 remains.Eventually the delivery sheath 118 and introducer sheath 116 are removedso that the device can degrade in the tissue tract as the tissue tractheals.

Operation of mechanism 55 depicted in FIGS. 7A, 7B, 7C, 7D, 7E, and 7Fdetails a tension member anchor 166 that can control the first or secondtension member as well as applying motion to the plunger 132. Thedelivery sheath 160 of device 55 locks into the introducer sheath 168 atposition 162. The delivery sheath 160 extends distal of the introducersheath 168 so that the distal section 175 can be placed in the vesseland otherwise manipulated to deploy the device.

Preferably, the bunchable material will bioabsorb or biodegrade as thewound heals so that months after the procedure and after the healingprocess is completed, there will be no evidence, or virtually noevidence of the material having been in the body. The proximal sectioncan have demarcations to encourage bunching of the section as thetension member is pulled. These demarcations can be perforation, orweakened lines, or supported lines that encourage bunching as a tensionmember is pulled. The demarcations along the material of the proximalsection can be equally spaced or unequally spaced. Thus, the bunchingareas of the section, depending on the spacing of the demarcations, canbe roughly equal, or may be in fact unequal. The structural benefitsprovided by the folded proximal section in the tissue tract includecreating an environment in the tract for the wound to heal and any bloodseeping from the puncture hole to coagulate.

The tension member is made of a biocompatible material, and can be abiodegradable material, provided that such material has enough initialtensile strength to do the work required of the tension member inpulling through the proximal section and bunching the material in theproximal section in the tissue tract. Tension members attached to thedistal section also need to control the rotation and seating of thedistal section and in the embodiments where the distal section isretracted from the vessel to also be able to accomplish that task. Thus,the tension member material can be PGLA, PGA, PLA, polydioxanone,polycaprolactone, polyhydroxybutyrate, suture, silk, Dacron orpropylene, or similar materials capable of holding and conveying atensile strength when the tension member is pulled to bunch or otherwisecontrol the device. The tension member may also be any of the materialslisted in other sections, provided the material can do the work that thetension member needs to do. The tension member material needs also to berelatively smooth so that upon pulling of the material to cause it tobunch the tension member will be able to slide through the material anddraw it together in the tissue tract.

The method of wound closure of the invention involves providing theclosure device and delivering it to the puncture wound and bunching itwithin the tissue tract. Typically the tissue tract will be accessedwith a delivery sheath that contains an unbunched, fully extendedversion of the closure device. The distal section of the device having adistal most rod-like fused section of material is placed through thepuncture hole and seated on the inside wall of the accessed vessel.Typically, the distal section will be in its narrowest configuration inorder to go through the puncture hole and then by manipulation of thetension member and plunger during deployment of the distal section inthe vessel, will be turned or rotated about 90 degrees to seat againstthe vessel wall inside the blood vessel. The proximal section of thedevice is deployed by a combination of pushing the plunger distallywhile the delivery sheath stays in the same place and pulling on thetension member to effect a bunching of the material of the proximalsection as the material leaves the delivery sheath. The introducersheath is always equal with or proximal of the tip of the deliverysheath as both are being withdrawn progressively from the tissue tract.Generally, the deployment of the proximal section includes using aplunger in the delivery sheath that pushes the proximal sectiondistally, and counters the pulling pressure from the tension member.After the proximal section is bunched in the tissue tract, the tensionmembers are released from the control mechanism allowing the deliverysheath and introducer sheath to be further withdrawn after which theexcess length of the tension members can be clipped at the surface ofthe skin. The tension members also act as safety tethers, maintainingattachment to the closure device in the event that it is improperlydeployed and has to be withdrawn and repositioned in the tissue tract,or removed and replaced with a new device. The bunching of the proximalsection is designed to provide structural impediment to bleeding in thetissue tract and to provide an environment for the wound to heal.

The method of the invention that uses the embodiment depicted in FIG. 6indicates the following steps: placing the closure device having adistal, middle and proximal section into a delivery sheath and placingthe delivery sheath into an introducer sheath in the tissue tract. Fromthis position, the delivery sheath is directed to the interior openingof the vessel or cavity. The plunger in the delivery mechanism anddelivery sheath is pushed within the delivery sheath distally enough todeploy the distal section into the vessel. The distal section is thenrotated about 90 degrees inside the vessel or cavity while pulling thefirst tension member at the same time that the plunger is pushed. Thisdual action provides the control to place the rotated distal sectionagainst the interior or the vessel or cavity by then pulling back on thedelivery sheath until said rotated distal section seats against thevessel wall. The introducer sheath and delivery sheath are graduallywithdrawn along the tissue tract while pushing of the plunger lodgedwithin the delivery sheath distally to release the middle and proximalsections in the tissue tract. The bunching of the proximal section isaccomplished by pulling the second tension member (while pushing theplunger). Once the proximal section is deployed from the delivery sheathand fully bunched the puncture wound is closed. Finally, in thisembodiment, the first tension member is pulled a second time to fold andwithdraw the distal section from the vessel into the tissue tract sothat it rests near the middle section, outside of the vessel. In thisway the vessel can resume full fluid flow without the distal sectionlodged at the vessel wall.

The invention includes methods of placing, deploying, positioning, andadjusting the devices, for the purpose of closing puncture wounds in apatient. The methods may be practiced using any sequence of necessarysteps possible in order to accomplish placing the device in the patientfor closing the puncture wound. The steps may be practiced in a specificorder or in any order deemed practical by the practitioner conductingthe procedure.

The mechanism that controls deployment of the device from the deliverysheath provides both tension on the tension members and motion with theplunger using the movement of the block to push the plunger into thedelivery sheath that is locked into the introducer sheath with a controlarm at the proximal end of the delivery sheath for approximatelysimultaneously applying tension on the tension member or members.

The invention is a closure device for closing a puncture wound, saiddevice deliverable in a delivery sheath, said puncture wound having alength along a tissue tract that resolves in an interior opening of avessel or cavity, said closure device comprising:

(a) a distal section for placing inside said interior opening of saidvessel or cavity, said distal section lodged in a delivery sheath havingproximal and distal ends, said delivery sheath capable of penetratingsaid wound along said length of said wound to pass through said interioropening and release said distal section, said released distal sectioncapable of rotation of about 90 degrees to provide resistance againstsaid interior opening,

(b) a proximal section connected to said distal section, said proximalsection comprising a bunchable material capable of bunching in saidtissue tract upon deployment, said proximal section released from saiddelivery sheath in an unbunched state, bunchable upon release,

(c) a tension member connected from said distal section through saidproximal section for rotating said distal section 90 degrees in saidinterior opening inside said vessel or cavity, and for bunching saidproximal section, upon release of said proximal section in said tissuetract, thereby closing said puncture wound with said distal sectionrotated 90 degrees inside said vessel or cavity and said proximalsection bunched in said tissue tract and

(d) a plunger lodged within said delivery sheath for rotating saiddistal section 90 degrees in coordination with said tension member bypushing said plunger towards said distal section and pulling saidtension member against the pushing of said plunger, thereby closing saidpuncture wound with said distal section rotated 90 degrees inside saidvessel or cavity and said proximal section bunched in said tissue tract.

The closure device can further comprise that said plunger is alsocapable of bunching said proximal section after rotation of said distalsection by pushing distally with said plunger while said tension memberis pulled proximally.

The closure device can further comprise a plunger for bunching saidproximal section by pushing distally with said plunger while saidtension member is pulled proximally.

The closure device contemplates wherein said tension member is loopedthrough said distal section and proximal section using a single tensionmember having first and second proximal ends. An embodiment alsocontemplates wherein said tension member passes through said distalsection and said proximal section once and is knotted at said distalsection, said tension member having a single end proximal to saidproximal section. Said looped tension member can be attached to itselfby a slip knot of a first end of the tension member around a second endof the tension member. The looped tension member can be fixed by oneknot in a first end of the tension member.

The distal and proximal sections can comprise a material selected fromthe group consisting of polyglycolytic acid (PGA), PGLA, PLA,polydioxanone, polycaprolactone, polyhydroxybutyrate, collagen, apolymer matrix, extracellular matrix, silk, Dacron, PTFE, EPTFE, abioabsorbable material, a biodegradable material, a biocompatiblematerial, a metal, a metal alloy, a plastic, an elastic material, apolymer, an inert material, a fused segment of material, a meltedsegment of material, a fabric, a braid, a weave, and a foldablematerial.

The tension member can comprise a material selected from the groupconsisting of polyglycolytic acid (PGA), PGLA, PLA, polydioxanone,polycaprolactone, polyhydroxybutyrate, collagen, a polymer matrix,extracellular matrix, silk, Dacron, suture, a bioabsorbable material, abiodegradable material, a biocompatible material, a metal, a metalalloy, a plastic, an elastic material, a polymer, an inert material, athread, and a strand.

The invention is also a closure device for closing a puncture wound,said device deliverable in a delivery sheath, said puncture wound havinga length along a tissue tract that resolves in an interior opening of avessel or cavity, said closure device comprising:

(a) a distal section for placing inside said interior opening of saidvessel or cavity, said distal section lodged in a delivery sheath havingproximal and distal ends, said delivery sheath capable of penetratingsaid wound along said length of said wound to pass through said interioropening and release said distal section, said released distal sectioncapable of rotation of about 90 degrees to provide resistance againstsaid interior opening,

(b) a proximal section connected to said distal section, said proximalsection comprising a bunchable material capable of bunching in saidtissue tract upon deployment, said proximal section also released fromsaid delivery sheath in an unbunched state, bunchable upon release,

(c) a first tension member connected to said distal section for rotatingsaid distal section 90 degrees inside said vessel or cavity and placingsaid distal section inside said interior opening of said vessel orcavity to provide resistance against said interior opening,

(d) a second tension member connected to said proximal section forbunching said bunchable material of said proximal section within saidtissue tract, thereby closing said puncture wound, and

(e) a plunger for pushing said distal section into said vessel androtating it 90 degrees in coordination with a pulling of said firsttension member, and for bunching said proximal section by pushingdistally with said plunger while said second tension member is pulledproximally.

The first tension member can be looped through said distal section andcomprises a slip knot formed of a first and second end of the firsttension member.

The second tension member can be looped through said proximal sectionand comprises a slip knot formed of a first and second end of the secondtension member.

The distal, and proximal sections can comprise a material selected fromthe group consisting of polyglycolytic acid (PGA), PGLA, PLA,polydioxanone, polycaprolactone, polyhydroxybutyrate, collagen, apolymer matrix, extracellular matrix, silk, Dacron, PTFE, EPTFE, abioabsorbable material, a biodegradable material, a biocompatiblematerial, a metal, a metal alloy, a plastic, an elastic material, apolymer, an inert material, a fused segment of material, a meltedsegment of material, a fabric, a braid, a weave, and a foldablematerial.

The first and second tension members can comprise a material selectedfrom the group consisting of polyglycolytic acid (PGA), PGLA, PLA,polydioxanone, polycaprolactone, polyhydroxybutyrate, collagen, apolymer matrix, extracellular matrix, silk, Dacron, suture, abioabsorbable material, a biodegradable material, a biocompatiblematerial, a metal, a metal alloy, a plastic, an elastic material, apolymer, an inert material, a thread, and a strand.

The invention is also a closure device for closing a puncture wound,said device deliverable in a delivery sheath, said puncture wound havinga length along a tissue tract that resolves in an interior opening of avessel or cavity, said closure device comprising:

(a) a distal section for placing inside said interior opening of saidvessel or cavity, said distal section lodged in a delivery sheath havingproximal and distal ends, said delivery sheath capable of penetratingsaid wound along said length of said wound to pass through said interioropening and release said distal section, said released distal sectioncapable of rotation of about 90 degrees to provide resistance againstsaid interior opening,

(b) a middle section connected to said distal section so that uponrotation of said distal section, said middle section exterior to saidvessel or cavity, remaining in connection with said distal section,

(c) a proximal section connected to said middle section, said proximalsection comprising a bunchable material capable of bunching in saidtissue tract upon deployment, said proximal section also released fromsaid delivery sheath in an unbunched state, bunchable upon release,

(d) a first tension member connected to said distal section for rotatingsaid distal section 90 degrees inside said vessel or cavity and placingsaid distal section inside said interior opening of said vessel orcavity to provide resistance against said interior opening,

(e) a second tension member connected to said proximal section forbunching said bunchable material of said proximal section within saidtissue tract, thereby closing said puncture wound, and

(f) a plunger for pushing said distal section into said vessel androtating it 90 degrees in coordination with a pulling of said firsttension member, and for bunching said proximal section by pushingdistally with said plunger while said second tension member is pulledproximally.

The first tension member is looped through said distal section andcomprises a slip knot formed from a first and second end of the firsttension member. The second tension member is looped through saidproximal section and comprises a slip knot formed from a first andsecond end of the second tension member.

The middle section can be narrower than said distal section so as toprovide minimal disturbance between said interior opening of said vesselor cavity and said tissue tract.

The distal, middle and proximal sections can comprise a materialselected from the group consisting of polyglycolytic acid (PGA), PGLA,PLA, polydioxanone, polycaprolactone, polyhydroxybutyrate, collagen, apolymer matrix, extracellular matrix, silk, Dacron, PTFE, EPTFE, abioabsorbable material, a biodegradable material, a biocompatiblematerial, a metal, a metal alloy, a plastic, an elastic material, apolymer, an inert material, a fused segment of material, a meltedsegment of material, a fabric, a braid, a weave, and a foldablematerial.

The first and second tension members can comprise a material selectedfrom the group consisting of polyglycolytic acid (PGA), PGLA, PLA,polydioxanone, polycaprolactone, polyhydroxybutyrate, collagen, apolymer matrix, extracellular matrix, silk, Dacron, suture, abioabsorbable material, a biodegradable material, a biocompatiblematerial, a metal, a metal alloy, a plastic, an elastic material, apolymer, an inert material, a thread, and a strand.

The invention is also a closure device for closing a puncture wound,said device deliverable in a delivery sheath, said puncture wound havinga length along a tissue tract that resolves in an interior opening of avessel or cavity, said closure device comprising:

(a) a distal section for placing inside said interior opening of saidvessel or cavity, said distal section lodged within a delivery sheathhaving proximal and distal ends, said delivery sheath capable ofpenetrating said wound along said length of said wound to pass throughsaid interior opening and release said distal section, said releaseddistal section capable of rotation of about 90 degrees to provideresistance against said interior opening,

(b) a middle section connected to said distal section so that uponrotation of said distal section, said middle section exterior to saidvessel or cavity, remaining in connection with said distal section,

(c) a proximal section connected to said middle section, said proximalsection comprising a bunchable material capable of bunching in saidtissue tract upon deployment, said proximal section also released fromsaid delivery sheath in an unbunched state, bunchable upon release,

(d) a first tension member connected to said distal section for rotatingsaid distal section 90 degrees inside said vessel or cavity and placingsaid distal section inside said interior opening of said vessel orcavity to provide resistance against said interior opening, and

(e) a second tension member connected to said proximal section forbunching said bunchable material of said proximal section within saidtissue tract, thereby closing said puncture wound,

(f) a plunger for pushing said distal section into said vessel androtating it 90 degrees in coordination with a pulling of said firsttension member, and for bunching said proximal section by pushingdistally with said plunger while said second tension member is pulledproximally,

(g) said first tension member capable of withdrawing said distal sectionfrom inside said vessel or cavity to be next to and folded into saidmiddle section within said tissue tract, thereby removing said distalsection from said vessel or cavity.

The middle section can be narrower than said distal section so as toprovide minimal disturbance between said interior opening of said vesselor cavity and said tissue tract.

The first tension member can be looped through said distal section, andresolve in two ends forming a slip knot.

The second tension member can be looped through said proximal sectionand resolves in a first end and a second end forming a slip knot forpulling said second tension member to bunch said proximal section.

The devices of the invention can optionally include a plunger forbunching the proximal section while a tension member that runs throughthe proximal section is pulled tight, either with an end knot or a slipknot configuration of the tension member.

The distal, middle and proximal sections can comprise a materialselected from the group consisting of polyglycolytic acid (PGA), PGLA,PLA, polydioxanone, polycaprolactone, polyhydroxybutyrate, collagen, apolymer matrix, extracellular matrix, silk, Dacron, PTFE, EPTFE, abioabsorbable material, a biodegradable material, a biocompatiblematerial, a metal, a metal alloy, a plastic, an elastic material, apolymer, an inert material, a fused segment of material, a meltedsegment of material, a fabric, a braid, a weave, and a foldablematerial.

The first and second tension members comprises a material selected fromthe group consisting of polyglycolytic acid (PGA), PGLA, PLA,polydioxanone, polycaprolactone, polyhydroxybutyrate, collagen, apolymer matrix, extracellular matrix, silk, Dacron, suture, abioabsorbable material, a biodegradable material, a biocompatiblematerial, a metal, a metal alloy, a plastic, an elastic material, apolymer, an inert material, a thread, and a strand.

The invention is also a closure device for closing a puncture wound,said device deliverable in a delivery sheath, said puncture wound havinga length along a tissue tract that resolves in an interior opening of avessel having fluid flow, said closure device comprising:

a short stiff front section capable of rotation 90 degrees upondeployment from said delivery sheath and upon pushing of a plunger alsolodged in said delivery sheath capable of placement inside said vesselfor seating said device in said vessel, said short front section havinga first tension member and said short front section connected to

a long bunchable back section that bunches upon deployment from saiddelivery sheath using said plunger to push it out from said deliverysheath in a plunging action and a second tension member running throughthe bunchable section to pull against said seated front section inopposition to said plunging action to release said long back sectionfrom said delivery sheath and to bunch it in said tissue tract.

The invention includes a method of closing a puncture wound, said woundhaving a length along a tissue tract that resolves in an interioropening of a vessel or cavity comprising:

placing the closure device for closing a puncture wound into a deliverysheath and placing said delivery sheath into an introducer sheath insaid tissue tract, and directing said delivery sheath to said interioropening of said vessel or cavity, said device deliverable in a deliverysheath, said puncture wound having a length along a tissue tract thatresolves in an interior opening of a vessel or cavity, said closuredevice comprising:

(a) a distal section for placing inside said interior opening of saidvessel or cavity, said distal section lodged in a delivery sheath havingproximal and distal ends, said delivery sheath capable of penetratingsaid wound along said length of said wound to pass through said interioropening and release said distal section, said released distal sectioncapable of rotation of about 90 degrees to provide resistance againstsaid interior opening,

(b) a proximal section connected to said distal section, said proximalsection comprising a bunchable material capable of bunching in saidtissue tract upon deployment, said proximal section released from saiddelivery sheath in an unbunched state, bunchable upon release, and

(c) a tension member connected from said distal section through saidproximal section for rotating said distal section 90 degrees in saidinterior opening inside said vessel or cavity, and for bunching saidproximal section, upon release of said proximal section in said tissuetract, thereby closing said puncture wound with said distal sectionrotated 90 degrees inside said vessel or cavity and said proximalsection bunched in said tissue tract, and

(d) a plunger lodged within said delivery sheath for rotating saiddistal section 90 degrees in coordination with said tension member bypushing said plunger towards said distal section and pulling saidtension member against the pushing of said plunger, thereby closing saidpuncture wound with said distal section rotated 90 degrees inside saidvessel or cavity and said proximal section bunched in said tissue tract,

pushing said plunger positioned within said delivery sheath distallyenough to deploy said distal section in said vessel,

rotating said distal section about 90 degrees inside said vessel orcavity while pulling said tension member and pushing said plungerdistally towards the puncture hole in the vessel,

placing said rotated distal section against said interior of said vesselor cavity by pulling back on said delivery sheath, pulling on saidtension member, and pushing on said plunger until said rotated distalsection seats against the vessel wall,

withdrawing said introducer sheath and delivery sheath gradually alongsaid tissue tract, pushing said plunger lodged within said deliverysheath distally to release said proximal section in said tissue tract,and

bunching said proximal section by pulling said tension member andpushing said plunger, thereby providing closure for said puncture woundin said vessel and along said tissue tract.

The invention also includes a method of closing a puncture wound, saidwound having a length along a tissue tract that resolves in an interioropening of a vessel or cavity comprising:

placing a closure device for closing a puncture wound into a deliverysheath and placing said delivery sheath into an introducer sheath insaid tissue tract, and directing said delivery sheath to said interioropening of said vessel or cavity, said device deliverable in a deliverysheath, said puncture wound having a length along a tissue tract thatresolves in an interior opening of a vessel or cavity, said closuredevice comprising:

(a) a distal section for placing inside said interior opening of saidvessel or cavity, said distal section lodged in a delivery sheath havingproximal and distal ends, said delivery sheath capable of penetratingsaid wound along said length of said wound to pass through said interioropening and release said distal section, said released distal sectioncapable of rotation of about 90 degrees to provide resistance againstsaid interior opening,

(b) a proximal section connected to said distal section, said proximalsection comprising a bunchable material capable of bunching in saidtissue tract upon deployment, said proximal section also released fromsaid delivery sheath in an unbunched state, bunchable upon release,

(c) a first tension member connected to said distal section for rotatingsaid distal section 90 degrees inside said vessel or cavity and placingsaid distal section inside said interior opening of said vessel orcavity to provide resistance against said interior opening, and

(d) a second tension member connected to said proximal section forbunching said bunchable material of said proximal section within saidtissue tract, thereby closing said puncture wound, and

(e) a plunger lodged within said delivery sheath for rotating saiddistal section 90 degrees in coordination with said first tension memberby pushing said plunger towards said distal section and pulling saidfirst tension member against the pushing of said plunger, therebyclosing said puncture wound with said distal section rotated 90 degreesinside said vessel or cavity and said proximal section bunched in saidtissue tract, pushing said plunger positioned within said deliverysheath distally enough to deploy said distal section in said vessel,

rotating said distal section about 90 degrees inside said vessel orcavity while pulling said first tension member and pushing said plungerdistally towards the puncture hole in the vessel,

placing said rotated distal section against said interior of said vesselor cavity by pulling back on said delivery sheath, pulling on said firsttension member, and pushing on said plunger until said rotated distalsection seats against the vessel wall,

withdrawing said introducer sheath and delivery sheath gradually alongsaid tissue tract, pushing said plunger lodged within said deliverysheath distally to release said proximal section in said tissue tract,and

bunching said proximal section by pulling said second tension member andpushing said plunger, thereby providing closure for said puncture woundin said vessel and along said tissue tract.

The invention is also a method of closing a puncture wound, said woundhaving a length along a tissue tract that resolves in an interioropening of a vessel or cavity comprising:

placing a closure device for closing a puncture wound, said devicedeliverable in a delivery sheath, said puncture wound having a lengthalong a tissue tract that resolves in an interior opening of a vessel orcavity into a delivery sheath and placing said delivery sheath into anintroducer sheath in said tissue tract, and directing said deliverysheath to said interior opening of said vessel or cavity, said closuredevice comprising:

(a) a distal section for placing inside said interior opening of saidvessel or cavity, said distal section lodged in a delivery sheath havingproximal and distal ends, said delivery sheath capable of penetratingsaid wound along said length of said wound to pass through said interioropening and release said distal section, said released distal sectioncapable of rotation of about 90 degrees to provide resistance againstsaid interior opening,

(b) a middle section connected to said distal section so that uponrotation of said distal section, said middle section exterior to saidvessel or cavity, remaining in connection with said distal section,

(c) a proximal section connected to said middle section, said proximalsection comprising a bunchable material capable of bunching in saidtissue tract upon deployment, said proximal section also released fromsaid delivery sheath in an unbunched state, bunchable upon release,

(d) a first tension member connected to said distal section for rotatingsaid distal section 90 degrees inside said vessel or cavity and placingsaid distal section inside said interior opening of said vessel orcavity in coordination with pushing on a plunger towards the puncturehole in the vessel to provide resistance against said interior opening,and

(e) a second tension member connected to said proximal section forbunching said bunchable material of said proximal section within saidtissue tract, thereby closing said puncture wound.

(f) a plunger lodged within said delivery sheath for rotating saiddistal section 90 degrees in coordination with said first tension memberby pushing said plunger towards said distal section and pulling saidfirst tension member against the pushing of said plunger, therebyclosing said puncture wound with said distal section rotated 90 degreesinside said vessel or cavity and said proximal section bunched in saidtissue tract,

pushing a plunger positioned within said delivery sheath distally enoughto deploy said distal section in said vessel

rotating said distal section about 90 degrees inside said vessel orcavity while pulling a first tension member and pushing said plungerdistally toward the puncture hole in the vessel,

placing said rotated distal section against said interior of said vesselor cavity by pulling back on the delivery sheath until said rotateddistal section seats against the vessel wall,

withdrawing said introducer sheath and delivery sheath gradually alongsaid tissue tract pushing said plunger lodged within said deliverysheath distally to release said middle and proximal sections in saidtissue tract, and

bunching said proximal section in said tissue tract by pulling saidsecond tension member, thereby providing closure for said puncturewound.

The invention also includes a method of closing a puncture wound, saidwound having a length along a tissue tract that resolves in an interioropening of a vessel or cavity comprising:

placing a closure device for closing a puncture wound, into a deliverysheath and placing said delivery sheath into an introducer sheath insaid tissue tract, and directing said delivery sheath to said interioropening of said vessel or cavity,

said device deliverable in a delivery sheath, said puncture wound havinga length along a tissue tract that resolves in an interior opening of avessel or cavity, said closure device comprising:

(a) a distal section for placing inside said interior opening of saidvessel or cavity, said distal section lodged within a delivery sheathhaving proximal and distal ends, said delivery sheath capable ofpenetrating said wound along said length of said wound to pass throughsaid interior opening and release said distal section, said releaseddistal section capable of rotation of about 90 degrees to provideresistance against said interior opening,

(b) a middle section connected to said distal section so that uponrotation of said distal section, said middle section exterior to saidvessel or cavity, remaining in connection with said distal section,

(c) a proximal section connected to said middle section, said proximalsection comprising a bunchable material capable of bunching in saidtissue tract upon deployment, said proximal section also released fromsaid delivery sheath in an unbunched state, bunchable upon release,

(d) a first tension member connected to said distal section for rotatingsaid distal section 90 degrees inside said vessel or cavity by pullingon said first tension member and pushing on said plunger and placingsaid distal section inside said interior opening of said vessel orcavity to provide resistance against said interior opening, and

(e) a second tension member connected to said proximal section forbunching said bunchable material of said proximal section within saidtissue tract, thereby closing said puncture wound,

(f) a plunger lodged within said delivery sheath for rotating saiddistal section 90 degrees in coordination with said first tension memberby pushing said plunger towards said distal section and pulling saidfirst tension member against the pushing of said plunger, therebyclosing said puncture wound with said distal section rotated 90 degreesinside said vessel or cavity and said proximal section bunched in saidtissue tract,

(g) said first tension member capable of withdrawing said distal sectionfrom inside said vessel or cavity to be next to and folded into saidmiddle section within said tissue tract, thereby removing said distalsection from said vessel or cavity.

pushing a plunger positioned within said delivery sheath distally enoughto deploy said distal section in said vessel rotating said distalsection about 90 degrees inside said vessel or cavity while pulling saidfirst tension member, and

placing said rotated distal section against said interior of said vesselor cavity by pulling back on the delivery sheath, pulling on said firsttension member, and pushing on said plunger towards the puncture hole inthe vessel until said rotated distal section seats against the vesselwall,

withdrawing said introducer sheath and delivery sheath gradually alongsaid tissue tract pushing said plunger lodged within said deliverysheath distally toward said puncture hole in said vessel to release saidmiddle and proximal sections in said tissue tract,

bunching said proximal section by pulling said second tension member andpushing on said plunger towards said vessel hole, thereby providingclosure for said puncture wound, and

pulling said first tension member a second time to withdraw said distalsection from said vessel into said tissue tract in close proximity withsaid middle section.

A kit can be assembled including a bunching closure device by itself orthe bunching closure device loaded in a delivery sheath. Directions foruse of the folding device and delivery sheath and for delivery anddeployment of the device are included. The kit is housed in a container,and a description of the materials that make up the device can beincluded.

Also, it is contemplated that any optional feature of the inventivevariations described may be set forth and claimed independently, or incombination with any one or more of the features described herein.Reference to a singular item, includes the possibility that there are aplurality of the same items present. More specifically, as used hereinand in the appended claims, the singular forms “a,” “an,” “said,” and“the” include plural referents unless specifically stated otherwise. Inother words, use of the articles allow for “at least one” of the subjectitem in the description above as well as the claims below. It is furthernoted that the claims may be drafted to exclude any optional element. Assuch, this statement is intended to serve as antecedent basis for use ofsuch exclusive terminology as “solely,” “only” and the like inconnection with the recitation of claim elements, or use of a “negative”limitation.

Without the use of such exclusive terminology, the term “comprising” inthe claims shall allow for the inclusion of any additional elementirrespective of whether a given number of elements are enumerated in theclaim, or the addition of a feature could be regarded as transformingthe nature of an element set forth in the claims. Except as specificallydefined herein, all technical and scientific terms used herein are to begiven as broad a commonly understood meaning as possible whilemaintaining claim validity.

All references cited are incorporated in their entirety. Although theforegoing invention has been described in detail for purposes of clarityof understanding, it will be obvious that certain modifications may bepracticed within the scope of the appended claims.

The invention claimed is:
 1. A medical closure device comprising: adistal section for placing through tissue, said distal section havingproximal and distal ends, and releasable from a delivery mechanism, amiddle section and proximal section connected to the distal section,said proximal section comprising a material to expand in the tissue, afirst tension member connected to said distal section for positioningsaid distal section in tissue, and a second tension member connected tosaid proximal section for expanding the material.
 2. The medical closuredevice of claim 1, further comprising an attachment to a deliverymechanism for deploying the closure device in tissue, the deliverymechanism having a plunger for providing resistance to the tensionmembers.
 3. The closure device of claim 1, selected from polyglycolyticacid (PGA), PGLA, PLA, polydioxanone, polycaprolactone,polyhydroxybutyrate, collagen, a polymer matrix, extracellular matrix,silk, Dacron, PTFE, EPTFE, a bioabsorbable material, a biodegradablematerial, a biocompatible material, a metal, a metal alloy, a plastic,an elastic material, a polymer, an inert material, a fused segment ofmaterial, a melted segment of material, a fabric, a braid, a weave, anda foldable material.
 4. The closure device of claim 2, selected frompolyglycolytic acid (PGA), PGLA, PLA, polydioxanone, polycaprolactone,polyhydroxybutyrate, collagen, a polymer matrix, extracellular matrix,silk, Dacron, suture, a bioabsorbable material, a biodegradablematerial, a biocompatible material, a metal, a metal alloy, a plastic,an elastic material, a polymer, an inert material, a thread, and astrand.
 5. A method of closing a medical wound, comprising: placing themedical closure device of claim 2 within tissue, pulling at least onetension member and pushing the plunger, thereby positioning the closuredevice in tissue.
 6. A method of closing a medical wound, comprising:placing the medical closure device of claim 2 within tissue, pulling atleast one tension member and pushing the plunger, thereby expandingmaterial of the closure device.
 7. A delivery mechanism for deployingthe closure device of claim 1 within tissue, the mechanism comprising:nested slidable members having increasing diameter, a plunger and ablock to push the plunger distally within a slidable member, andconnection with one or more tension members for gathering and holdingtension to control placement and expansion of the closure device.